FDA.reportPublic FDA data

Jenx (Daytot)

Primary DI
05056235223207
Brand
Jenx (Daytot)
Company
JENX LIMITED
Model
207-600
Device description
Joey Fabric Bundle (inc Size 1 & 2)
Published
2025-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILTAdaptor, Recreational

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILTAdaptor, RecreationalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056235223207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056235223207050562352232075056235223207

GMDN Terms#

Term, Definition table
TermDefinition
Assistive crawler/mobility boardA device used to provide a person with a disability with a means of mobility, typically without the attendance of another person. It is a wheeled device upon which the person lies or sits, enabling him/her to move around by pushing on the floor with their arms or legs. This device will enhance the user's ability for self-transportation in a local environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
291659639
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056235223184Jenx (Daytot)207-6012025-08-08
05056235223191Jenx (Daytot)207-6022025-08-08
05056235223214Jenx (Daytot)207-6042025-08-08
05056235223221Jenx (Daytot)207-6052025-08-08
05056235223276Jenx (Daytot)207-6062025-08-08
05056235223283Jenx (Daytot)207-6112025-08-08
05056235223290Jenx (Daytot)207-6122025-08-08
05056235223306Jenx (Daytot)207-6132025-08-08
05056235223313Jenx (Daytot)207-6142025-08-08
05056235223320Jenx (Daytot)207-6152025-08-08
05056235223337Jenx (Daytot)208-6002025-08-08
05056235223344Jenx (Daytot)208-6012025-08-08
05056235223351Jenx (Daytot)208-6022025-08-08
05056235223405Jenx (Daytot)208-6132025-08-08
05056235203858Jenx COVH12024-05-10
05056235203865Jenx COVH22024-05-10
05056235203872Jenx COVH32024-05-10
05056235203889Jenx COVH4-012024-05-10
05056235203896Jenx COVH4-022024-05-10
05056235203902Jenx COVH4-032024-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650204Lynk Hook Module standardmacu4 GmbHILT2025-11-23
04262429650211Lynk Push Module standardmacu4 GmbHILT2025-11-23
04262429650228Lynk Hold STD Modulemacu4 GmbHILT2025-11-23
04262429650235Lynk Clic Modulemacu4 GmbHILT2025-11-23
04262429650242Lynk Clic Head 360°macu4 GmbHILT2025-11-23
04262429650259Lynk Clic Head 70°macu4 GmbHILT2025-11-23
04262429650266Lynk Clic Head 0°macu4 GmbHILT2025-11-23
04262429650273Lynk Clic Adaptermacu4 GmbHILT2025-11-23
04262429650327Lynk Clic Lock Modulemacu4 GmbHILT2025-11-23
04262429650334Lynk Clic Lock Head 360°, STDmacu4 GmbHILT2025-11-23
04262429650341Lynk Clic Lock Head 70°, STDmacu4 GmbHILT2025-11-23
04262429650358Lynk Clic Lock Head 0°, STDmacu4 GmbHILT2025-11-23
04262429650365Lynk Clic Lock Adaptermacu4 GmbHILT2025-11-23
04262429650372Lynk Hold Lock Modulemacu4 GmbHILT2025-11-23
04262429650389Lumo Cuff, STD-SML-Amacu4 GmbHILT2025-11-23
04262429650396Lumo Shovel, STDmacu4 GmbHILT2025-11-23
04262429650402Lumo Hold, Lockmacu4 GmbHILT2025-11-23
04262429650419Lumo Roll, STDmacu4 GmbHILT2025-11-23
04262429650426Lumo Clamp, STDmacu4 GmbHILT2025-11-23
04262429650433Lynk Clic Lock Head 70°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650440Lynk Clic Lock Head 0°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650457Lynk Clic Lock Head 360°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650464Lynk Clic Lock Head 70°, FLATmacu4 GmbHILT2025-11-23
04262429650471Lynk Clic Lock Head 360°, FLATmacu4 GmbHILT2025-11-23
04262429650488Lynk Clic Lock Head 0°, FLATmacu4 GmbHILT2025-11-23
04262429650495Lumo Cuff, STD-SML-Bmacu4 GmbHILT2025-11-23
04262429650501Lumo Cuff, STD-SML-Cmacu4 GmbHILT2025-11-23
04262429650518Lumo Cuff, STD-SML-Dmacu4 GmbHILT2025-11-23
04262429650525Lumo Cuff, STD-SML-Emacu4 GmbHILT2025-11-23
04262429650570Lumo Cuff, STD-MED-Amacu4 GmbHILT2025-11-23